Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225, Germany
NCT Number: NCT03101696
The gold standard to induce coronary hyperemia for measurement of fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) is adenosine, but it exerts several side effects due to its unspecific action on adenosine receptors. The specific A2a-receptor agonist, regadenoson, has been shown to dilate coronary arteries and enables FFR measurements. The aim of the study was to evaluate whether simultaneous measurement of FFR, CFR and IMR is feasible, safe and effective within regadenoson-induced hyperemia.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Düsseldorf, 40225, Germany
Fractional flow reserve (FFR), coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR) provide significant information on the conductance of coronary macro- and microcirculation.
FFR-based functional assessment of coronary artery disease has proven to be superior to purely morphologic assessment and thereby guides therapy decision. IMR is a pressure-temperature derived parameter for quantifying microcirculatory resistance, which has been proven to be relatively independent of epicardial stenosis severity when taking collateral flow into account. IMR is increased in patients with acute myocardial infarction and microvascular obstruction (MVO) as assessed by contrast-enhanced CMR and predicts left ventricular function and enddiastolic volumes at 6 month independently of initial infarct size.
Most interestingly, even in the absence of obstructive coronary artery disease, IMR is elevated in more than 20% of patients presenting with chest pain. The clinical meaning for this finding has to be elucidated.
FFR, CFR and IMR can only be measured under conditions of minimal coronary resistance with the need for coronary hyperemia. The current "gold standard" to induce hyperemia in the assessment of coronary conductance is adenosine. However, adenosine is known to cause side effects (bronchospasm and disturbances in atrioventricular conduction) due to its unselective action on all adenosine receptors. Besides that, adenosine requires a body weight adapted dosing and continuous infusion. However, alternative routes like intracoronary injection show good correlation compared with the intravenous route and side effects can be reduced. In contrast, regadenoson, a specific A2A receptor agonist, exhibits negligible side effects. It can be administered intravenously as a non-body weight adapted bolus via peripheral vein without the need for transfemoral delivery. Thus, patients with a transradial access for cardiac catheterization might benefit the most from inducing hypermedia via peripheral vein. It has already been shown that regadenoson increases coronary blood flow yielding comparable values for FFR and indexes of perfusion in SPECT. However, the duration and stability of regadenoson-induced hyperemia might be insufficient for a simultaneous measurement of FFR, CFR and IMR, which has not been tested so far.
The aim of the present study is to evaluate whether simultaneous measurement of the parameters FFR, CFR and IMR under regadenoson-induced hyperemia is feasible, safe and effective in patients with stable coronary artery disease undergoing a transradial procedure
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Coronary angiography with indication of FFR measurement
Exclusion criteria
Time frame: Baseline
Description: the proximal aortic (Pa) and distal arterial pressure (Pd) are recorded and RadiAnalyzer Xpress™ control unit automatically calculates FFR as Pd/Pa
Time frame: Baseline
The RadiAnalyzer Xpress™ calculates CFR as Tmnr/Tmnh
Time frame: Baseline
Using the derived Pd and transit mean times under hyperemia (Tmnh), it will be calculated apparent IMR as Pd×Tmnh. All IMR values are also corrected by Yong's formula (IMRcorr=Pa×Tmnh×([1.35×Pd/Pa]-0.32) to adjust for the influence of collateral flow.
Heinrich-Heine University, Duesseldorf
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03016221
Cardiovascular Diseases, Erythema
Landquart, Kanton Graubünden, Switzerland
View Trial DetailsNCT05706181
Aging Well, Body Temperature Changes
Fort Worth, Texas, United States
View Trial DetailsNCT07521293
Arrhythmias, Cardiac, Atrial Fibrillation
Ankara, Turkey (Türkiye)
View Trial DetailsNCT05903846
Behavior, Breast Feeding
Ağrı, Turkey (Türkiye)
View Trial Details